Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
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ClinicalTrials.gov Identifier: NCT01541202 |
Recruitment Status
:
Terminated
(Sponsor has designed another study to replace the current study)
First Posted
: February 29, 2012
Last Update Posted
: December 21, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Heart Failure | Drug: rhNRG-1 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 679 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | August 2017 |
Actual Study Completion Date : | August 2017 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
placebo in addition to standard therapy
|
Drug: Placebo
10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks
|
Experimental: rhNRG-1
rhNRG-1 in addition to standard therapy
|
Drug: rhNRG-1
10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks
|
- All-cause mortality [ Time Frame: 1 year ]
- sudden death [ Time Frame: 1 year ]
- death caused by cardiovascular events [ Time Frame: 1 year ]
- rehospitalization [ Time Frame: 1 year ]
- hospitalization caused by worsening heart failure [ Time Frame: 1 year ]
- cardiac function [ Time Frame: 1 year ]
- NYHA functional classification [ Time Frame: 1 year ]
- 6 minute walking distance [ Time Frame: 1 year ]
- quality of life [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 18 and 75, both sex.
- Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- NYNA functional class II OR III.
- Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month.
- Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for the last one month.
- Capable of signing the informed consent form.
Exclusion Criteria:
- new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
- NYNA functional class I OR IV.
- Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
- Ischemic heart failure without recanalization or with recanalization in recent six months.
- acute MI in the last 3 months.
- unstable angina.
- Patients with acute pulmonary edema or acute hemodynamic disorder.
- Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month.
- Patients with right heart failure caused by pulmonary disease.
- Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (>50ml).
- Cardiac surgery or cerebrovascular accident within recent six months.
- Preparing for heart transplantation or CRT, or has received CRT.
- Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate).
- Serious hepatic or renal dysfunction (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
- Serum potassium <3.2 mmol/L or >5.5 mmol/L.
- Systolic blood pressure <90mmHg or >160mmHg.
- Pregnant or plan to pregnant.
- Patients who participated in any clinical trial in the recent three months.
- Subject with a life expectancy less than 6 months as assessed by the investigator.
- Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute.
- History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
- Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
- Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541202

Principal Investigator: | Runlin Gao, MD, Ph.D | Cardiovascular Institute and Fuwai Hospital |
Responsible Party: | Zensun Sci. & Tech. Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01541202 History of Changes |
Other Study ID Numbers: |
ZS-01-305 |
First Posted: | February 29, 2012 Key Record Dates |
Last Update Posted: | December 21, 2017 |
Last Verified: | February 2012 |
Keywords provided by Zensun Sci. & Tech. Co., Ltd.:
chronic heart failure neuregulin mortality |
Additional relevant MeSH terms:
Heart Failure Heart Diseases Cardiovascular Diseases |